Quality Systems & Performance
QMS strategy and governance, CAPA and nonconformance systems, management review, quality metrics and executive reporting, eQMS selection.
Life Sciences
Quality & Technical Operations Advisory
Quality problems rarely belong to Quality alone.
Brentiva helps pharmaceutical and medical-device companies solve quality and technical-operations problems that affect technical execution, operations and business performance.
Discuss a challenge →Where problems start
The visible finding is often one part of a larger problem.
Brentiva looks past the event, finding or procedural failure to the system that keeps producing it.
What shows upWhere it often starts
What shows upCAPAs close on time, and the same problems come back.
Where it often startsGovernance. Nobody owns the decision, the evidence bar is unclear, and management review never asks whether the actions worked.
What shows upValidation is running months late.
Where it often startsProcess knowledge that was lost in technology transfer, so each protocol has to rediscover how the process behaves.
What shows upA supplier's quality keeps slipping.
Where it often startsSplit ownership between Quality, Supply Chain and R&D, and technical expectations that were never written into the agreement.
What shows upThe remediation passed inspection, and the team is drowning in it.
Where it often startsControls added for every finding instead of sized to the risk, so the system costs more to run than the protection it adds.
What clients get
Better decisions. Stronger systems. Sustainable performance.
Better decisions
Material risk separated from unnecessary complexity, and a path that is scientifically defensible, proportionate and practical.
Stronger systems
The governance, interfaces and process knowledge behind a recurring problem fixed, so the symptom stops returning.
Sustainable performance
Solutions your organization can operate, resource and maintain without sacrificing patient protection or long-term business health.
Services
Four service lines for pharmaceutical and medical‑device organizations.
Remediation & Inspection Readiness
FDA 483 and Warning Letter remediation, audit and inspection readiness for ISO 13485, MDSAP and EU MDR, systemic corrective action, backlog recovery.
Validation, Technology Transfer & External Partners
Process, analytical-method and computer-system validation, calibration and metrology, technology transfer, supplier and CDMO quality.
Interim Quality Leadership
Interim or fractional head of quality, leadership of complex quality programs, executive reporting.
Focused programs: U.S. Market Entry · Quality Due Diligence and Integration · Laboratory Quality and Data Integrity
Start with a Quality System Diagnostic
A fixed-scope review of how your quality system performs in practice, ending in a prioritized plan you can act on with or without further support.
- AssessEvidence from records, data and the people who run the system.
- PlanPriorities sized to risk, with owners and a realistic sequence.
- ExecuteHands-on delivery alongside your team.
- SustainMetrics and governance that keep results in place after the engagement ends.
Founder
From the analytical lab to the management review.
Robert R. Díaz
Founder & Principal
Robert is a chemist whose career runs from research and analytical development to quality engineering, remediation and quality-systems leadership in pharmaceuticals and medical devices.
He has managed quality systems for a sterile, implantable medical-device division of one of the world's largest medical-technology companies; led remediation and U.S. market-entry programs for pharmaceutical manufacturers in the U.S., Latin America, Europe and Asia; and led analytical development and technology transfer for a blockbuster injectable product at a global pharmaceutical company.
His research in nanomaterials for diagnostics and wound care produced peer-reviewed publications and a published U.S. patent application.
Career history on LinkedIn →Selected experience
- Co-wrote, with a four-consultant team, the remediation plan and Warning Letter response for a manufacturer in Asia, and led one of its three implementation workstreams. FDA accepted the corrective actions.
- Built a U.S.-compliant analytical validation framework for an EU manufacturer, supporting a successful FDA pre-approval inspection for their first U.S. launch.
- Rebuilt a failing calibration program: on-time returns from 25% to 90%, turnaround from 30 to 6 days, and annual spend down 55%.
- Lead host for external ISO 13485, EU MDR and MDSAP audits. The audit-readiness and response program he implemented achieved zero nonconformances across those audits.
Contact
Discuss a challenge.
Engagements are shaped around the problem: a fixed-scope diagnostic, a defined project, ongoing advisory support or interim leadership. Describe what you're facing in a few lines.
Or emailrobert@brentiva.com